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CTRI Number  CTRI/2022/03/040919 [Registered on: 08/03/2022] Trial Registered Prospectively
Last Modified On: 07/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of Sadabhadradyam churna and Vrehddhatrayadi kwath in BPH.  
Scientific Title of Study   A clinical study to evaluate the efficacy of sadabhadradyam churna and vrehddhatrayaadi kwath in the management of benign prostratic hyperplasia(BPH). 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sanjive Kumar Maithil 
Designation  PG Scholar 
Affiliation  M.M.M Govt.Ayurved college,Udaipur,Rajasthan. 
Address  PG Dept.of kayachikitsa M.M.M Govt.Ayurved college,Udaipur,Rajasthan.

Udaipur
RAJASTHAN
313001
India 
Phone  9549900972  
Fax    
Email  nir2006la@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Indumati Sharma 
Designation  Asso.Professor and Guide 
Affiliation  M.M.M GOVT.AYURVED COLLEGE,UDAIPUR 
Address  PG Dept.of Kayachikitsa M.M.M Govt.Ayurved College,Udaipur.

Udaipur
RAJASTHAN
313001
India 
Phone  7976972310  
Fax    
Email  drindusharma4@gmail.com  
 
Details of Contact Person
Public Query  
Name  DRINDUMATI SHARMA 
Designation  ASSO.PROFESSOR & GUIDE 
Affiliation  M.M.M GOVT.AYURVED COLLEGE,UDAIPUR 
Address  PG Dept.of kayachikitsa M.M.M GOVT.AYURVED COLLEGE,UDAIPUR


RAJASTHAN
313001
India 
Phone  7976972310  
Fax    
Email  drindusharma4@gmail.com  
 
Source of Monetary or Material Support  
M.M.M Govt.Ayurved College,Udaipur,Rajasthan.  
 
Primary Sponsor  
Name  MMM GovtAyurved CollegeUdaipurRajasthan 
Address  M.M.M Govt.Ayurved College Radaji Circle,Ambamata,Udaipur,Rajasthan. PIN:313001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sanjive Kumar Maithil  Rajyavaidya Premshankar Sharma Ayurved Chikitsalaya  0PD No:2, PG Dept. of kayachikitsa Associated hospital,M.M.M Govt.Ayurved College,Udaipur,Rajasthan.
Udaipur
RAJASTHAN 		 09549900972

nir2006la@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,MMM Govt.Ayurved College,Udaipur,Rajasthan.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N400||Benign prostatic hyperplasia without lower urinary tract symptoms. Ayurveda Condition: VATASHTHILA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: SADABHADRADYAM CHURNA, Reference: YOGRATNAKARA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: VREHDDHATRAYAADI KWATH, Reference: BHAISHAJYA RATNAVALI, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -SUGAR), Additional Information: -
3Intervention ArmDrugClassical(1) Medicine Name: SADABHADRADYAM CHURNA, Reference: YOGRATNAKARA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: VREHDDHATRAYAADI KWATH, Reference: BHAISHAJYA RATNAVALI, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -SUGAR), Additional Information: -
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Male 
Details  1)Signs and symptoms of benign prostate hyperplasia
2)Residual urine <120 ml
 
 
ExclusionCriteria 
Details  1)Residual urine >120 ml
2)Prostatic carcinoma
3)Complete urine retention 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in signs and symptoms of benign prostatic hyperplasia.  2 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in signs and synptoms of benign prostatic hyperplasia.  15 days,30 days and 45 days. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/03/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a interventional multiple arm clinical trial  to evaluate the efficacy of sadabhadradyam churna and vrehddhatrayadi kwath in the management of benign prostatic hyperplasia.First Group is given   sadabhadradyam churna ,second group is given  vrehddhatrayadi kwath and third group is given both the medicines.  
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